Auditing independence

Under a comprehensive quality system the QU can expect an expanded and more visible role within the organization with greater accountability to and interaction with upper management. The QU should ideally be independent of the other organizational units to assure clear delineation of responsibility and authority and avoid conflicts. In certain instances, such as auditing, independence or objectivity is central... 

Personnel independent of the work practices being examined should conduct these audits. Independence implies the ability to demonstrate a measnre of impartiality. It does not necessarily mean that the person conducting the self-inspection is from a separate department or fnnction. A peer review is perfectly acceptable. 

The importance of safety audits, independent safety assessment, and independent safety regulation has been mentioned many times in this book. It is worth recapping on the differences between these three activities ... 

An organisation such as the example above includes sub groups for each of the main activities and a support (or services) group to manage information and procurement. Auditing commitments may be fulfilled by an independent in-house team or by external auditors. 

The GMP details certain requirements for the quahty system, such as the independence and responsibihties of the quahty control unit. It requires such activities as internal audit to monitor GMP conformance, employee training, complaint investigation, failure analysis, and verification of proper manufacture and test by QC prior to release of the batch. 

Audit (Process Safety Audit) An inspection of a plant or process unit, drawings, procedures, emergency plans, and/or management systems, etc., usually by an independent, impartial team. 

In addition to fulfilling the in-house requirements for quality control, state and local air monitoring networks which are collecting data for compliance purposes are required to have an external performance audit on an annual basis. Under this program, an independent organization supplies externally calibrated sources of air pollutant gases to be measured by the instrumentation undergoing audit. An audit report summarizes the performance of the instruments. If necessary, further action must be taken to eliminate any major discrepancies between the internal and external calibration results. 

Knowledge that the declared intentions are actually being followed. (This may be gained by personal assessment or reliance on independent audits.)... 

Remote locations shall be audited as they support a site but cannot obtain independent ISO/TS 16949 certification. A division that does not have the capability to meet all requirements cannot seek ISO/TS 16949 certification e.g. Personnel, Purchasing divisions cannot be registered separately as they could be under ISO 10011. 

The standard requires that internal quality audits be carried out by personnel independent of those having direct responsibility for the activity being audited. 

By being independent of the audited activities, the auditor is unaware of the pressures, the excuses, the informal instructions handed down and can examine operations objectively without bias and without fear of reprisals. It is for this reason that it was considered appropriate for the auditor to have no direct responsibility for the work being audited i.e. audits carried out by a manager, supervisor, or foreman of his/her own department or section do not qualify as internal quality audits in ISO 9001 1994. However, they will qualify under ISO 9000 2000. 

Separate independent quality audit departments could be set up, staffed with trained auditors. 

The team should be realistic about the time required to see improvements in end-of-pipe measures in most cases the pilot project success will be measured on efficiency improvements and other in-process measures alone. In this case it is important to demonstrate that all PSM and ESH issues are being managed. You should consider having a management systems audit (validation) conducted by a group independent of the integration project team. This may be done in conjunction with the next scheduled audit. This may be a corporate or divisional audit function or a consultant engaged specifically for this task. 

If there are no existing measures of PSM and ESH, do not panic Use the results of an independent audit of the management systems conducted before and after the pilot study or use the results of existing audits. 

Some deficiencies in the integrated systems may be seen at once others will be visible only after project resources have been withdrawn and the system is self-supporting. It is important to examine the integration straight after installation and a few months later. These reviews should draw on the results of the independent audits and should involve staff from the pilot... 

The regular internal auditing of a quality system is a fundamental requirement. These audits should be conducted by persoimel independent of the operational area being audited for example a quality department should not audit its own activities. The results of such audits, together with those from outside inspection bodies, will invariably identify areas for improvement. 

In accordance to GCP, the sponsor should appoint clinical trial monitors. These act as the main communication interface between the sponsor and the trial site, and should regularly visit the site to oversee that the trials are being conducted and correctly documented in accordance with the protocol and GCP. Reports should be supplied to the sponsor after each visit. It is also good practice for the sponsor to establish an auditing system for independently verifying that the activities in relation to the collection and processing of data at the trial site, and at related laboratories or sponsor s facilities, are conducted in accordance with applicable protocols, procedures, regulations, GCP and GLP. 

Because of the complexity of computer hardware and software and because of the intricacy of a risk assessment, the FDA has to all intents and purposes adopted an indirect regulatory posture. Regulated companies are informally urged to conduct independent audits of Part 11 compliance, utilizing in-house or consultant expertise. The agency can then review the details of the audit report and the credentials for experience, expertise, and independence of the auditor. Follow-up investigation of speciflc points can then be laser-focused on specific areas of concern. 

The effectiveness of a QA-related independent Part 11 audit is dependent on the checklist or audit plan utilized. Here, provided as a model, is a two-part audit checklist. The depth of the evidence and support required is dependent on the results of the risk assessment All high-, medium-, or low-risk systems should be subject to the same general questions. 

Procedures and controls shall include use of secure, computer-generated time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records. 

There must be systems in place to monitor the study while it is in progress and to check that all systems are working in accordance with GLP requirements, to record any problems identified and to ensure that remedial action is taken. The person responsible for these quality assurance procedures must be independent of the study being audited. In large organizations, there may be a separate Quality Assurance unit but this will not be practical in smaller organizations. 

You may have already experienced an audit so would be able to identify an internal audit. This is an inspection carried out by staff of the laboratory but who are independent of the work activity carried out in the area being audited, i.e. the auditee. Both the second-party and... 

Audit A systematic, independent and documented process for obtaining evidence and evaluating it objectively to determine the extent to which set procedures or requirements have been fulfilled. 

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